Status:
RECRUITING
Study of 18F-FFNP Breast PET/MRI
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This clinical trial will investigate an estrogen-regulated parameter as an early measure of endocrine therapy response: progesterone receptor (PR) protein with a progestin-based radioligand, 18F-fluor...
Detailed Description
Primary Objective • Determine the diagnostic accuracy of 18F-FFNP PET/MRI for predicting response to presurgical endocrine therapy. Secondary Objectives * Determine the repeatability of quantitativ...
Eligibility Criteria
Inclusion
- Postmenopausal status defined by either
- prior bilateral oophorectomy
- age greater than or equal to 60 years of age
- age less than 60 years of age and amenorrheic for 12 or more months in the absence of prior chemotherapy, tamoxifen, toremifene or ovarian suppression and FSH and estradiol in the postmenopausal range per local normal range (Group 2 only)
- Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in diameter by any imaging modality
- Biopsy-proven PR-positive invasive breast cancer
- Breast MRI planned or performed before surgery
- Definitive surgical excision of the primary tumor planned without neoadjuvant therapy; defined as therapy (chemotherapy, targeted therapy, radiation therapy or endocrine therapy) given to decrease the size of the tumor prior to planned surgery.
Exclusion
- Inability or unwillingness to provide informed consent to the study
- HER2-positive breast cancer, as defined by immunohistochemical staining 3+ OR positive by in situ hybridization (Group 2 only)
- PR and Ki67 IHC slides or FFPE tissue blocks from clinical breast biopsy not available
- Patients who have completed neoadjuvant chemotherapy, endocrine therapy, targeted therapy, surgical resection, or radiation for the current biopsy-proven malignancy
- Patients who are planning to undergo anastrozole as standard of care neoadjuvant therapy
- Patients who are currently taking aromatase inhibitors or ER antagonists (tamoxifen, raloxifene)
- Patients with breast expanders
- Patients who are pregnant or lactating
- Patients with a contraindication to gadolinium-based contrast agents, including allergy or impaired renal function (per UW Health Guidelines)
- Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FFNP
- Patients with history of allergic reaction to anastrozole (Group 2 only)
- Patients in liver failure as judged by the patient's physician
- Patients with standard contraindications to MRI (per UW Health Guidelines)
- Patients requiring conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met:
- The patient has their own prescription for the medication
- The informed consent process is conducted prior to the self-administration of the medication.
- The patient comes to the research visit with a driver.
- Patients unable to lie prone for 45 minutes for imaging
- Patients taking hormone replacement therapy or over-the-counter products/supplements/herbal preparation with potential estrogenic effects who are unwilling to discontinue these agents during the timeframe of the study until surgery.
Key Trial Info
Start Date :
September 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT06086704
Start Date
September 25 2024
End Date
January 1 2030
Last Update
October 1 2025
Active Locations (1)
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1
UW Carbone Cancer Center
Madison, Wisconsin, United States, 53792